FDA device listing
LXMJ23L Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider Latching Handle, Without Nano-coating 5mm…
FDA device listing 1391441577 · STRYKER CORP.
Key facts
| Proprietary names | LXMJ23L Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider Latching Handle, Without Nano-coating 5mm - 23cm,LXMJ23S Remanufactured LigaSure XP Maryland Jaw Open Sealer/Divider One-step Sealing, Without Nano-coating 5mm - 23cm,LXMJ37L Remanufactured LigaSure XP Maryland Jaw Laparoscopic Sealer/Divider Latching Handle, Without Nano-coating 5mm -,LXMJ37S Remanufactured LigaSure XP Maryland… |
|---|---|
| Owner/operator | STRYKER CORP. |
| Owner/operator number | 1811755 |
| Premarket submissions | K260636 |
| Product codes | GEI, NUJ |
| Device names | GEI - Electrosurgical, Cutting & Coagulation & Accessories, NUJ - Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4400 |
| Review panels | General & Plastic Surgery |
| Registered establishments | Stryker Sustainability Solutions, Stryker Sustainability Solutions - Chandler, Stryker Tijuana Operations |
| Establishment registrations | 3009350690, 3020163307, 3030153385 |
| FEI numbers | 3009350690, 3020163307, 3030153385 |
| Establishment operations | Remanufacturer, Reprocessor of Single Use Devices, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database